Health product recall

Veritcal Mandibular Angle %u2122 & Temporal Shell %u2122 Implant and Composite %u2122 EPTFE-Coated Extended Anatomical Chin (2020-10-22)

Starting date:
October 22, 2020
Posting date:
February 12, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74983

Last updated: 2021-02-12

Affected Products

A. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Left
B. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Right
C. Vertical Mandibular Angle (TM) Sizers
D. Temporal Shell (TM) Implant-Size: 7mm, Left
E. Temporal Shell (TM) Implant-Size: 7mm, Right
F. Composite(TM) EPTFE-Coated Extended Anatomical Chin-Size: Small

Reason

Device was shipped to Canada without appropriate market clearance.

Affected products

A. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Left

Lot or serial number

886835

Model or catalog number

VMA-7L

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES

B. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Right

Lot or serial number

886441

Model or catalog number

VMA-7R

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES

C. Vertical Mandibular Angle (TM) Sizers

Lot or serial number

882810

Model or catalog number

VMA-SIZ-NS

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES

D. Temporal Shell (TM) Implant-Size: 7mm, Left

Lot or serial number

885147

Model or catalog number

TS-07L

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES

E. Temporal Shell (TM) Implant-Size: 7mm, Right

Lot or serial number

883066

Model or catalog number

TS-07R

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES

F. Composite(TM) EPTFE-Coated Extended Anatomical Chin-Size: Small

Lot or serial number

EPTFE-EAC-S

Model or catalog number

EPTFE-EAC-S

Companies
Manufacturer
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES